HYPURIN BOVINE NEUTRAL

Active substance: INSULIN BOVINE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

HYPURIN® BOVINE RANGE OF INSULIN
INJECTION

Read all of this leaflet carefully before
you inject your insulin.
-  eep this leaflet. You may need to
K
read it again while you are receiving
your treatment.
- f you have any further questions,
I
please ask your doctor, pharmacist
or diabetes nurse.
-
This
medicine
has
been
prescribed for you. It must not
be shared with other patients. It may
harm them even if their symptoms
are the same as yours.

In this leaflet:
1. What Hypurin® is and what it is used for
2. Before you receive Hypurin®
3. How to use Hypurin®
4. Possible side effects
5. How to store Hypurin®
6. Further information
1. WHAT HYPURIN® IS AND WHAT IT IS USED FOR
The name of your medicine is Hypurin Bovine Insulin. Hypurin
Bovine is the brand name for a range of highly purified bovine
(cow) insulin injections.
Hypurin Bovine Neutral is a sterile, clear solution of bovine
insulin (100 international units/ml). It is short acting.
Hypurin Bovine Isophane is a sterile, white suspension of
bovine insulin (100 international units/ml) with protamine
sulphate and zinc chloride in water. It is longer acting than
Hypurin Bovine Neutral.
Hypurin Bovine Lente is a sterile, white suspension of bovine
insulin (100 international units/ml) with zinc oxide in water.
It is fairly long acting.
Hypurin Bovine Protamine Zinc is a sterile, white suspension
of bovine insulin (100 international units/ml) mixed with
protamine sulphate and zinc chloride in water. It is very
long acting.
What Hypurin is used for
Hypurin contains insulin which is a natural hormone, made
by a gland called the pancreas. Insulin plays a key role in the
way the body uses carbohydrate, fat and protein.
Hypurin Bovine is used for the treatment of insulindependent diabetes mellitus. In this type of diabetes, your
pancreas does not make enough insulin to control the level
of sugar in your blood. It can be treated by controlling your
diet and taking insulin. Hypurin Bovine has been prescribed
for you as a substitute for your own insulin.
2. BEFORE YOU RECEIVE HYPURIN®
You should not inject Hypurin Bovine insulin if:
•  ou have symptoms of hypoglycaemia (low blood sugar
y
or ‘hypo’ - see the section on hypoglycaemia in section
4 ‘Possible side effects’)
•  ou have ever had an allergic reaction to insulin or any
y
of the other ingredients in Hypurin Bovine (see ‘What
Hypurin contains’ in section 6 ‘Further information’).
If any of the above applies to you, you should not inject
Hypurin®.
Talk to your doctor before taking this medicine if you are
taking pioglitazone, as your risk of heart failure may be
increased.
Taking other medicines
Taking another medicine while you are using insulin can
affect how it or the other medicine works. Tell your doctor
or pharmacist if you are taking any other medicine before
you start taking insulin.
This includes medicines you may have bought yourself
without a prescription.
Medicines that can affect the way insulin works are;
•  teroids, both corticosteroids, used to treat a range of
S
allergic conditions, and anabolic steroids, used to treat
various metabolic disorders.
•  evothyroxine, used for an underactive thyroid gland.
L
•  nti-inflammatory drugs such as aspirin and NSAIDs
A
such as ibuprofen.
•  yclophosphamide, used to treat a wide range of
C
tumours.
• soniazid, used to treat tuberculosis (TB).
I
•  ome drugs used to treat high blood pressure such as
S
beta blockers, ACE inhibitors, nifedipine, clonidine or
guanethidine.
• Some drugs such as adrenaline, which are used to treat
shock.
• ome drugs used to treat mental illness such as
S
chlorpromazine, amitriptyline, fluoxetine and MAOIs
such as phenelzine.
• hiazide diuretics or loop diuretics, used to control
T
excess water.
•  ral contraceptives (birth control pills).
O
•  ctreotide, an anti-hormone preparation.
O
•  ntimalarial drugs, such as chloroquine or quinine.
A
• Diazoxide, used to treat high blood pressure or low blood
sugar.
•  isopyramide or quinidine, used to treat an irregular
D
heartbeat.
•  enfluramine, used to treat obesity.
F
•  ibrates or gemfibrozil, used to regulate lipids.
F
•  ebendazole, used to treat threadworm.
M

•  xytetracycline, an antibiotic.
O
• Pentoxifylline, used to treat leg ulcers and problems with
blood circulation in the legs.
• Testosterone.
Alcohol and smoking can also affect the way insulin works.
If you have any doubts about your medicine then discuss
things more fully with your doctor, pharmacist or diabetes
nurse.
Pregnancy and breast-feeding
Before using this medicine you should let your doctor know
if you are pregnant or wish to become pregnant or start
breast-feeding.
Particularly careful control of your diabetes and prevention
of hypoglycaemia is important for your health and the health
of your baby.
Insulin requirements should be assessed frequently by an
experienced diabetes physician during pregnancy, after
delivery and whilst breast-feeding.
Driving and using machines
Your ability to concentrate or react may be reduced if you
have hypoglycaemia. This might put yourself and others at
risk when you are driving a car or operating machinery. You
should contact your doctor about the advisability of driving
if you have:
f
• requent episodes of hypoglycaemia
•  educed or lack of warning signs of hypoglycaemia.
r
Important information about some of the ingredients
of Hypurin
Zinc, protamine and the preservatives m-cresol and phenol
may cause allergic reactions.
3. HOW TO USE HYPURIN®
What dose is needed?
There is no ‘standard’ dose of insulin. Each person with
diabetes has their own dose calculated according to their
needs. Your doctor will decide which dose is best for you
and which insulin to use.
Always follow your doctor’s instructions exactly and also
follow any special instructions or warnings that appear on
the label that the pharmacist has put on the package.
Dosage adjustments of Hypurin
Patients with disease of the liver, kidneys, adrenal, pituitary
or thyroid glands, or coeliac disease (symptoms may include
severe diarrhoea and unintentional weight loss) may need
lower doses.
This dose may alter during illness (including infection and
surgery), injury, emotional stress, during puberty, around
the time of a menstrual period, and during pregnancy and
after delivery. Lactating women may also require dosage
adjustments. It may also change with your diet and lifestyle,
particularly if you are exercising more.
Patients transferred to Hypurin Bovine Insulins from other
types of insulin may require dosage adjustments.
Newly diagnosed diabetic patients may require dosage
adjustments during the first weeks, months or years of
treatment.
If you do not understand or are in any doubt ask your doctor,
pharmacist or diabetes nurse.
Advice and checks to be made when using Hypurin
Bovine Insulin
Y
•  ou must keep a close watch on your blood sugar by
testing your glucose levels regularly in your blood or
urine.
• our urine should be tested for ketones at regular
Y
intervals.
•  e aware that insulin resistance can occur, particularly
B
in patients who have lipid disorders (usually this will be
diagnosed by blood tests), hypertension (high blood
pressure) or heart disease. Stress can also contribute
to insulin resistance.
I
• f your doctor has asked you to increase the frequency
or dose of your insulin treatment in order to improve
your sugar levels, you may at some point lose some
of the warning symptoms that usually occur when your
blood sugar is falling too low (hypoglycaemia). These
symptoms include shakiness, pounding heartbeat,
sweating and feeling anxious.
•  ou may also lose some of the warning symptoms of
Y
hypoglycaemia if you have had repeated attacks of
hypoglycaemia, if control of your blood sugar is greatly
improved, if you have a long history of diabetes, or if
you are also taking certain other medicines, such as
beta blockers (used to treat high blood pressure and
angina) or clonidine (used to treat high blood pressure)
I
• f you are elderly, you may have more severe episodes
of hypoglycaemia and some of the warning symptoms
may change, be weaker or be missing.
•  e aware that activities such as taking a hot bath,
B
sunbathing, or using a sunbed or sauna can increase
the rate at which insulin is absorbed and increase the
risk of hypoglycaemia.
Injection sites
Recommended injection sites include the upper arms,
thighs, buttocks and lower abdomen. It may be preferable
to use those areas that are less visible. Each time you inject
your insulin you should use a different spot in the same
general area. Change to a different injection area each week.
Hypurin Bovine Isophane, Hypurin Bovine Lente or
Hypurin Bovine Protamine Zinc should not be injected
into a vein.
Hypurin Bovine Neutral may be injected into a vein, but only
by a doctor in an emergency.

Injecting Hypurin
Your doctor or diabetes nurse will advise you on how to
inject your insulin.
•  heck that the vial in the carton has the same label as
C
on the carton and that different types of Hypurin Bovine
have not been mixed up.
•  o not use Hypurin Bovine that has been frozen or
D
contains lumps that do not disappear on mixing.
•  ash and dry your hands.
W
•  lean the rubber plug on the vial, but do not remove it.
C
• If you are using Hypurin Bovine Isophane, Hypurin Bovine
Lente or Hypurin Bovine Protamine Zinc, roll the vial
gently between your palms or invert it several times to
mix the contents immediately before use.
•  ypurin Bovine Neutral does not need to be mixed. It
H
should be a clear, colourless solution and not contain
any particles.
•  efore withdrawing your insulin from the vial, draw air
B
into the syringe equal to the amount of insulin to be drawn
up. Push the needle through the rubber plug of the vial
and inject the air into the vial. This will make it easier for
you to withdraw the insulin.
•  eaving the needle in the vial, turn the vial upside down
L
making sure the needle tip stays below the surface of
the insulin. Slowly fill the syringe with slightly more than
your usual dose of insulin. Push the plunger back to
your correct dose, expelling any air bubbles into the
vial. Take the needle out of the vial. You are now ready
to inject your insulin.
•  inch up the skin at the injection site. Stick the needle
P
in fully at right angles. Do not release the skin. Push the
plunger down to empty the syringe keeping the needle in
place for a count of five seconds. Release the pinched
up skin and take the needle out. There is no need to
massage the area.
•  nce the vial is opened the insulin must only be used
O
by the same patient.
If your doctor recommends it, Hypurin Bovine Neutral can
be mixed with Hypurin Bovine Isophane or Hypurin Bovine
Lente in the same syringe. If you need to do this, draw the
Hypurin Bovine Neutral into the syringe before the Hypurin
Bovine Isophane or Hypurin Bovine Lente. This should be
demonstrated to you before you attempt to do it yourself.
Use the injection immediately.
Hypurin Bovine Neutral and Hypurin Bovine Protamine Zinc
should not be mixed together.
If you think you have received too much Hypurin
If you think you have received too much Hypurin, contact
your doctor or diabetes nurse immediately. Symptoms
of an overdose include weakness, sweating, trembling,
nervousness, excitement and irritability which, if untreated,
could lead to collapse and coma.
4. POSSIBLE SIDE EFFECTS
Like all medicines, insulin may cause side effects in some
patients when treatment is first started or if there is a change
in the type of insulin used.
These include:
•  ypoglycaemia) (see section “Treating hypoglycaemia”
H
below)
• swelling (oedema)
r
•  edness, itching or swelling around the area of injection
•  tinging, or sensations of warmth or burning at the site
s
of injection
• hickening or pitting of the skin in the areas used for
t
injection (lipodystrophy)
• rash
• pain caused by nerve damage
•  hortness of breath or wheezing
s
•  levels of potassium, which can cause muscle
low
weakness, twitching or abnormal heart rhythm
(hypokalaemia)
• weight gain
• nausea.
Rarely the following side effects may occur:
•  llergic reactions and generalised swelling (oedema)
a
• severe allergic reactions that cause difficulty in breathing
or dizziness.
If you experience any other side effects or feel that your
insulin is affecting you badly please contact your doctor,
pharmacist or diabetes nurse.
Hypoglycaemia (“hypo” or insulin reaction) symptoms
Hypoglycaemia means low blood sugar. The symptoms of
a “hypo” are:
•  ale face, sweating
p
p
•  alpitations, rapid heartbeat, heart disease (symptoms
may include chest pain and shortness of breath)
• hunger
• cramps
• deep breathing
w
• eakness, drowsiness, yawning, fatigue, reduced
consciousness
• ltered behaviour, aggression, confusion, irritability,
a
anxiety, nervousness, restlessness, excitement,
trembling
d
•  ifficulty in finding words, difficulty in concentration
• fits
•  lurred vision and/or double vision, slurred speech
b
• ingling or numbness of the nose, mouth, fingers, or
t
toes, paralysis
•  eadache, excess fluid in the brain (symptoms may
h
include headache, loss of co-ordination), brain
damage (symptoms may include forgetfulness, learning
difficulties).

Why might hypoglycaemia occur?
Hypoglycaemia may occur for the following reasons (or
occasionally for no apparent reason):
•  issing or postponing a meal
m
or eating less than the correct
dietary allowance
• taking more exercise than usual
• 
injecting the wrong dose of
insulin
• episodic heavy alcohol intake –
‘binge drinking’.
Untreated “hypos” can have serious
consequences. It is important to
recognise the symptoms and treat
hypoglycaemia early.
Treating hypoglycaemia
•  lways carry glucose tablets or sugar lumps with you
A
wherever you go.
• At the first warning sign of hypoglycaemia, stop what you
are doing and take five glucose tablets or three sugar
lumps, preferably with water. You should begin to feel
better almost immediately.
• If you do not feel better in ten minutes repeat the glucose
tablets or sugar lumps.
• f the “hypo” happens shortly before a meal or snack,
I
treat the “hypo” and have your meal as soon as you can.
• If a meal is not due, take the quick-acting glucose tablets
or sugar lumps and follow them with some longer-acting
carbohydrate food like a sandwich or biscuits.
•  ecause of the risk of a “hypo” you should carry an
B
identification card or wear an identity bracelet or
necklace carrying details of your name, address, doctor
and insulin treatment. It is also important that relatives,
friends and colleagues know that you have diabetes and
are taking insulin so that they can recognise symptoms
of a “hypo” and help if necessary.
5. HOW TO STORE HYPURIN®
Keep all vials and syringes out of the reach and sight
of children.
•  ypurin Bovine vials should be stored in a refrigerator
H
between 2°C - 8°C. Once in use, the cartridge can be
kept at room temperature (up to 25°C) for 28 days after
which it should be discarded.
•  o not use this medicine if the expiry date on the label
D
has passed or if the insulin has been frozen. The expiry
date refers to the last day of the month.
• 
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Hypurin Bovine Contains
Hypurin Bovine Neutral is a sterile, clear solution of bovine
insulin (100 international units/ml). It also contains m-cresol,
phenol, glycerol and sodium phosphate.
Hypurin Bovine Isophane is a sterile, white suspension of
bovine insulin (100 international units/ml) with protamine
sulphate and zinc chloride in water. It also contains m-cresol,
phenol, glycerol and sodium phosphate.
Hypurin Bovine Lente is a sterile, white suspension of bovine
insulin (100 international units/ ml) with zinc oxide in water.
It also contains sodium chloride, sodium acetate and methyl
parahydroxybenzoate.
Hypurin Bovine Protamine Zinc is a sterile, white suspension
of bovine insulin (100 international units/ml) mixed with
protamine sulphate and zinc chloride in water. It also
contains phenol, glycerol and sodium phosphate.
What Hypurin Bovine looks like and contents of the
pack
Hypurin Bovine is available in glass vials, which contain 10ml
of solution or suspension.
Hypurin Bovine Neutral and Hypurin Bovine Isophane are
also available in glass cartridges which contain 3ml of
solution or suspension for use in pen injectors.
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name

Reference Number

Hypurin® Bovine Neutral

29831/0125

Hypurin® Bovine Isophane

29831/0120

Hypurin® Bovine Protamine Zinc

29831/0128

Hypurin® Bovine Lente

29831/0129

This is a service provided by the Royal National Institute
of Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
Leaflet prepared: October 2011.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)